ML18044A260

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3/16/2018 Letter to S. Flaherty Minnesota Revised Final Regulations to Rats Id 2013-1, and Proposed Regulations to Rats Ids 2015-1, 2015-2, 2015-3, 2015-4, 2015-5, and Other Provisions Not Associated with a Rats Id
ML18044A260
Person / Time
Issue date: 03/16/2018
From: Linda Howell
Office of Nuclear Material Safety and Safeguards
To: Flaherty S
State of MN, Dept of Health
Beardsley M
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UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 March 16, 2018 Sherrie Flaherty, MHP, DC, Supervisor Radioactive Materials Unit Minnesota Department of Health PO Box 64975 St. Paul, MN 55164-0975

Dear Dr. Flaherty:

We have reviewed the proposed and revised final regulations to the Minnesota Radioactive Materials Rules, Minnesota Rules, Chapter 4731, received by our office on January 29, 2018.

These regulations were reviewed by comparison to the equivalent U.S. Nuclear Regulatory Commission (NRC) rules and Regulation Amendment Tracking System Identification Numbers (RATS IDs) 2013-1, 2015-1, 2015-3, 2015-4, 2015-5, and other provisions not associated with a RATS ID, as identified in the enclosed State Regulation Status (SRS) Data Sheet. We discussed our review of the regulations with you on March 13, 2018.

As a result of our review, we have four comments that have been identified in the enclosure.

Please note that we have limited our review to regulations required for compatibility and/or health and safety. Under our current procedure, a finding that the Minnesota regulations meet the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final Minnesota regulations. However, we have determined that if your proposed regulations were adopted, incorporating our comments and without other significant change, they would meet the compatibility and health and safety categories established in the Office of Nuclear Material Safety and Safeguards (NMSS) Procedure SA-200, Compatibility Categories and Health and Safety Identification for NRC Regulations and Other Program Elements.

We request that when the proposed regulations are adopted and published as final regulations, a copy of the as published regulations be provided to us for review. As requested in NMSS Procedure SA-201, Review of State Regulatory Requirements, please highlight the final changes, and provide a copy to Division of Materials Safety, Security, State, and Tribal Programs, NMSS.

The SRS Data Sheet summarizes our knowledge of the status of other Minnesota regulations, as indicated. Please let us know if you note any inaccuracies, or have any comments on the information contained in the SRS Data Sheet. This letter, including the SRS Data Sheet, is posted on the NMSS State Communication Portal: https://scp.nrc.gov/rulemaking.html.

S. Flaherty If you have any questions regarding the comments, the compatibility and health and safety categories, or any of the NRC regulations used in the review, please contact Michelle Beardsley, State Regulation Review Coordinator, at (267) 884-2305 (Michelle.Beardsley@nrc.gov ) or Lizette Roldan Otero at (817) 200-1596 (Lizette.Roldan@nrc.gov ).

Sincerely,

/RA Paul Michalak for/

Linda Howell, Acting Deputy Director Division of Materials Safety, Security, State and Tribal Programs Office of Nuclear Material Safety and Safeguards

Enclosures:

1. Compatibility Comments
2. Minnesota SRS Data Sheet

S. Flaherty

SUBJECT:

MINNESOTA REVISED FINAL REGULATIONS TO RATS ID 2013-1, AND PROPOSED REGULATIONS TO RATS IDS 2015-1, 2015-2, 2015-3, 2015-4, 2015-5, AND OTHER PROVISIONS NOT ASSOCIATED WITH A RATS ID DISTRIBUTION: SP 07 DPiccarillo, RSAO OFFICE ASPB ASPB OGC ASPB:BC MSTR:DD NAME LRoldan MBeardsley APessin NLO PMichalak PMichalak for via email LHowell DATE 2/9/18 2/13/18 3/13/18 3/16/18 3/16/18 ML18044A260 OFFICIAL RECORD COPY Package ML18032A473

COMPATIBILITY COMMENTS ON MINNESOTA PROPOSED REGULATIONS STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS 1 4731.0406 71.17 2015-3 C Quality assurance requirements Subpart 2 71.101(b) and and (c)(1) In part 4731.0406, Subpart 2 and part 4731.0409 4731.0409, Subpart 2, Minnesota Subpart 2 needs to replace the references to NRC with their State agency as follows:

Subp. 2. Approved quality assurance program. Except as otherwise provided in parts 4731.0400 to 4731.0424, the general license issued under subpart 1 applies only to a licensee who has a quality assurance program approved by the NRC [insert Minnesota agency]

as complying with Code of Federal Regulations, title 10, part 71, subpart H.

Minnesota needs to make the change indicated above in order to meet the Compatibility Category B designation assigned to 10 CFR 71.17 and the Compatibility Category C designation assigned to 71.101(b) and (c)(1).

2 4731.0420 71.101(g) 2015-3 C Quality assurance requirements Subpart 1 Minnesota needs to revise part 4731.0420, Subpart 1, Item D by replacing item A with items A-C. One of the requirements of 10 CFR 71.101(g) is that the Agreement States program must meet the requirements of 10 CFR 34.31(b). Item A of part 4731.4090, subpart 2 only corresponds to part of 10 CFR 34.31(b)(1). The remainder of 10 CFR 34.31(b)(1) (i.e.,

replacement components meet design specifications) is covered in item B and 10 CFR 34.31(b)(2) is covered in item C, respectively, of part 4731.4090, subpart 2.

Enclosure 1

STATE SECTION NRC SECTION RATS ID CATEGORY SUBJECT and COMMENTS Minnesota needs to make the change indicated above in order to meet the Compatibility Category C designation assigned to 10 CFR 71.101(g).

3 4731.2950 10 CFR Part 20 2015-5 B Standards for protection against Subpart 2.F. Appendix G radiation In Part 4731.2950, Subpart 2.F.,

Minnesota needs to remove the phrase Office of Information Resource Management and add in its place the phrase Office of the Chief Information Officer.

Minnesota needs to make the change indicated above in order to meet the Compatibility Category B designation assigned to 10 CFR Part 20, Appendix G.

4 4731.0419 71.97(a) NA B Advanced notification of shipment of irradiated fuel and nuclear waste Minnesota needs to include the NRC in these notifications so that an Agreement State licensee will notify the NRC of a shipment of licensed material that meets the requirements of 10 CFR 71.97(b), that would enter or cross through a non-Agreement State.

Minnesota needs to make the change indicated above in order to meet the Compatibility Category B designation assigned to 10 CFR 71.97(a).

EDITORIAL COMMENT STATE SECTION Preliminary Determinations 4731.0414 Minnesota should revise its proposed language to part 4731.0414 by deleting the word part before 71.85 and replacing it with the word section or

§ as there is no part 71.85 in NRC regulations.

2

STATE REGULATION STATUS State: Minnesota Tracking Ticket Number: 18-21 Date: 3/16/2018

[ # amendment(s) reviewed identified by a

  • at the beginning of the equivalent NRC requirement.]

RATS ID NRC Chronology Identification Date Due for Incoming Outgoing Notes State Adoption Letter Package 1991-1 Safety Requirements for Radiographic Equipment 01/10/1994 Final No Comments Minnesota has adopted Final Part 34 ML050140452 03/04/2005 Regulations equivalent to RATS ID:

55 FR 843 ML050690100 1997-5.

(Superceded by 1997-5) 1991-2 ASNT Certification of Radiographers none Not Required Not Required Minnesota has adopted Final Part 34 Regulations equivalent to RATS ID:

56 FR 11504 1997-5.

(Superceded by 1997-5) 1991-3 Standards for Protection Against Radiation 01/01/1994 Final No Comments Part 20 ML050140452 03/04/2005 56 FR 23360; 56 FR 61352; 57 FR 38588; 57 FR ML050690100 57877; 58 FR 67657; 59 FR 41641; 60 FR 20183; 1991-4 Notification of Incidents 10/15/1994 Final No Comments Parts 20, 30, 31, 34, 39, 40 and 70 ML050140452 03/04/2005 56 FR 64980; ML050690100 1992-1 Quality Management Program and 01/27/1995 Final No Comments Minnesota has adopted Final Misadministrations ML050140452 03/04/2005 Regulations equivalent to RATS ID:

Part 35 ML050690100 2002-2.

56 FR 34104 (Superceded by 2002-2)

Enclosure 2

1992-2 Eliminating the Recordkeeping Requirements none Not Required Not Required These regulation changes are not for Departures from Manufacturer's Instructions required to be adopted for purposes Parts 30 and 35 of Compatibility.

57 FR 45566 1993-1 Decommissioning Recordkeeping and License 10/25/1996 Final No Comments Termination: Documentation Additions [Restricted ML050140452 03/04/2005 areas and spill sites] ML050690100 Parts 30 and 40 58 FR 39628 1993-2 Licensing and Radiation Safety Requirements for 07/01/1996 Final No Comments Irradiators ML050140452 03/04/2005 Part 36 ML050690100 58 FR 7715 1993-3 Definition of Land Disposal and Waste Site QA 07/22/1996 Not Applicable Not Applicable Minnesota does not have authority Program to regulate this material under its Part 61 Agreement.

58 FR 33886 1994-1 Self-Guarantee as an Additional Financial none Not Required Not Required These regulation changes are not Mechanism required to be adopted for purposes Parts 30, 40 and 70 of Compatibility.

58 FR 68726; 59 FR 1618 1994-2 Uranium Mill Tailings Regulations: Conforming 07/01/1997 Not Applicable Not Applicable Minnesota does not have the NRC Requirements to EPA Standards authority to regulate this material Part 40 under its Agreement.

59 FR 28220 1994-3 Timeliness in Decommissioning Material Facilities 08/15/1997 Final No Comments Parts 30, 40 and 70 ML050140452 03/04/2005 59 FR 36026 ML050690100 1995-1 Preparation, Transfer for Commercial Distribution, 01/01/1998 Final No Comments and Use of Byproduct Material for Medical Use ML050140452 03/04/2005 Parts 30, 32 and 35 ML050690100 59 FR 61767; 59 FR 65243; 60 FR 322 2

1995-2 Frequency of Medical Examinations for Use of 03/13/1998 Final No Comments Respiratory Protection Equipment ML050140452 03/04/2005 Part 20 ML050690100 60 FR 7900 1995-3 Low-Level Waste Shipment Manifest Information 03/01/1998 Final No Comments and Reporting ML050140452 03/04/2005 Parts 20 and 61 ML050690100 60 FR 15649; 60 FR 25983 1995-4 Performance Requirements for Radiography 06/30/1998 Final No Comments Minnesota has adopted Final Equipment ML050140452 03/04/2005 Regulations equivalent to RATS ID:

Part 34 ML050690100 1997-5.

60 FR 28323 (Superceded by 1997-5) 1995-5 Radiation Protection Requirements: Amended 08/14/1998 Final No Comments Definitions and Criteria ML050140452 03/04/2005 Parts 19 and 20 ML050690100 60 FR 36038 1995-6 Clarification of Decommissioning Funding 11/24/1998 Final No Comments Requirements ML050140452 03/04/2005 Parts 30, 40 and 70 ML050690100 60 FR 38235 1995-7 Medical Administration of Radiation and Radioactive 10/20/1998 Final No Comments Minnesota has adopted Final Materials ML050140452 03/04/2005 Regulations equivalent to RATS Parts 20 and 35 ML050690100 IDs: 2002-2 and 2005-2.

60 FR 48623 (Superceded by 2002-2 and 2005-2) 1996-1 Compatibility with the International Atomic Energy 04/01/1999 Final No Comments Minnesota has adopted Final Agency ML050140452 03/04/2005 Regulations equivalent to RATS ID:

Part 71 ML050690100 2004-1.

60 FR 50248; 61 FR 28724 (Superceded by 2004-1) 3

1996-2 One Time Extension of Certain Byproduct, Source 02/15/1999 Not Required Not Required These regulation changes are not and Special Nuclear Materials Licenses required to be adopted for purposes Parts 30, 40 and 70 of Compatibility.

61 FR 1109 1996-3 Termination or Transfer of Licensed Activities: 06/17/1999 Final No Comments Record keeping Requirements ML050140452 03/04/2005 Parts 20, 30, 40, 61 and 70 ML050690100 61 FR 24669 1997-1 Resolution of Dual Regulation of Airborne Effluents 01/9/2000 Final No Comments of Radioactive Materials; Clean Air Act ML050140452 03/04/2005 Part 20 ML050690100 61 FR 65120 1997-2 Recognition of Agreement State Licenses in Areas 02/27/2000 Final No Comments Under Exclusive Federal Jurisdiction Within an ML050140452 03/04/2005 Agreement State ML050690100 Part 150 62 FR 1662 1997-3 Criteria for the Release of Individuals Administered 05/29/2000 Final No Comments Radioactive Material ML050140452 03/04/2005 Parts 20 and 35 ML050690100 62 FR 4120 1997-4 Fissile Material Shipments and Exemptions 02/10/2000 Not Required Not Required These regulation changes are not Part 71 required to be adopted for purposes 62 FR 5907 of Compatibility. (See STP-97-078)

(Superceded by 2004-1)

Minnesota has adopted Final Regulations equivalent to RATS ID:

2004-1.

1997-5 Licenses for Industrial Radiography and Radiation 06/27/2000 Final No Comments Safety Requirements for Industrial Radiography ML050140452 03/04/2005 Operations ML050690100 Parts 30, 34, 71 and 150 62 FR 28947 4

1997-6 Radiological Criteria for License Termination 08/20/2000 Final No Comments Parts 20, 30, 40, and 70 ML050140452 03/04/2005 62 FR 39057 ML050690100 1997-7 Exempt Distribution of a Radioactive Drug 01/02/2001 Final No Comments Containing One Microcurie of Carbon-14 Urea ML050140452 03/04/2005 Part 30 ML050690100 62 FR 63634 1998-1 Deliberate Misconduct by Unlicensed Persons 02/12/2001 Final No Comments Parts 30, 40, 61, 70, 71 and 150 ML050140452 03/04/2005 63 FR 1890; 63 FR 13773 ML050690100 1998-2 Self-Guarantee of Decommissioning Funding by 07/01/2001 Not Required Not Required These regulation changes are not Nonprofit and Non-Bond-Issuing Licensees required to be adopted for purposes Parts 30, 40 and 70 of Compatibility.

63 FR 29535 1998-3 License Term for Medical Use Licenses 07/10/2001 Not Required Not Required These regulation changes are not Part 35 required to be adopted for purposes 63 FR 31604 of Compatibility. (See STP-98-074)

(Superceded by 2002-2)

Minnesota has adopted Final Regulations equivalent to RATS ID:

2002-2.

1998-4 Licenses for Industrial Radiography and Radiation 07/09/2001 Final No Comments Safety Requirements for Industrial Radiographic ML050140452 03/04/2005 Operations ML050690100 Part 34 63 FR 37059 1998-5 Minor Corrections, Clarifying Changes, and a Minor 10/26/2001 Final No Comments Policy Change ML050140452 03/04/2005 Parts 20, 32, 35, 36 and 39 ML050690100 63 FR 39477; 63 FR 45393 1998-6 Transfer for Disposal and Manifests: Minor 11/20/2001 Final No Comments Technical Conforming Amendment ML050140452 03/04/2005 Part 20 ML050690100 63 FR 50127 5

1999-1 Radiological Criteria for License Termination of 06/11/2002 Not Applicable Not Applicable Minnesota does not have the Uranium Recovery Facilities authority to regulate this material Part 40 under its Agreement.

64 FR 17506 1999-2 Requirements for Those Who Possess Certain 10/04/2002 Not Required Not Required These regulation changes are not Industrial Devices Containing Byproduct Material to required to be adopted for purposes Provide Requested Information of Compatibility.

Part 31 64 FR 42269 1999-3 Respiratory Protection and Controls to Restrict 02/02/2003 Final No Comments Internal Exposure ML050140452 03/04/2005 Part 20 ML050690100 64 FR 54543; 64 FR 55524 2000-1 Energy Compensation Sources for Well Logging 05/17/2003 Final No Comments and Other Regulatory Clarifications ML050140452 03/04/2005 Part 39 ML050690100 65 FR 20337 2000-2 New Dosimetry Technology 01/08/2004 Final No Comments Parts 34, 36 and 39 ML050140452 03/04/2005 65 FR 63750 ML050690100 2001-1 Requirements for Certain Generally Licensed 02/16/2004 Final No Comments Industrial Devices Containing Byproduct Material ML050140452 03/04/2005 Parts 30, 31 and 32 ML050690100 65 FR 79162 2002-1 Revision of the Skin Dose Limit 04/05/2005 Final No Comments Part 20 ML050140452 03/04/2005 67 FR 16298 ML050690100 2002-2 Medical Use of Byproduct Material 10/24/2005 Final No Comments Parts 20, 32 and 35 ML050140452 03/04/2005 67 FR 20249 ML050690100 2003-1 Financial Assurance for Materials Licensees 12/03/2006 Final No Comments Parts 30, 40 and 70 ML073201223 12/14/2007 68 FR 57327 ML073470558 6

2004-1 Compatibility With IAEA Transportation Safety 10/01/2007 Final No Comments Standards and Other Transportation Safety ML073201223 12/14/2007 Amendments ML073470558 Part 71 69 FR 3697 2005-1 Security Requirements for Portable Gauges 07/11/2008 Final No Comments Containing Byproduct Material ML073201223 12/14/2007 Part 30 ML073470558 70 FR 2001 2005-2 Medical Use of Byproduct Material - Recognition of 04/29/2008 Final No Comments Specialty Boards ML073201223 12/14/2007 Part 35 ML073470558 70 FR 16336; 71 FR 1926 2005-3 Increased Controls for Risk-Significant Radioactive 12/01/2005 License No Comments Sources (NRC Order EA-05-090) Condition 11/18/2005 70 FR 72128 ML053220236 ML053220444 2006-1 Minor Amendments 03/27/2009 Final No Comments Parts 20, 30, 32, 35, 40 and 70 ML073201223 12/14/2007 71 FR 15005 ML073470558 2006-2 National Source Tracking System - Serialization 02/06/2007 Final No Comments Requirements ML090550203 03/23/2009 Part 32 with reference to Part 20 Appendix E ML090760101 71 FR 65685 2006-3 National Source Tracking System 01/31/2009 Final No Comments Part 20 ML090260708 03/23/2009 71 FR 65685, 72 FR 59162 ML090760101 License No Comment Condition 02/06/2009 ML090260708 ML090290322 2007-1 Medical Use of Byproduct Material - Minor 10/29/2010 Final No Comments Corrections and Clarifications ML090550203 03/23/2009 Parts 32 and 35 ML090760101 72 FR 45147, 54207 7

2007-2 Exemptions From Licensing, General Licenses, and 12/17/2010 Final No Comments Distribution of Byproduct Material: Licensing and ML090550203 03/23/2009 Reporting Requirements ML090760101 Parts 30, 31, 32 and 150 72 FR 58473 2007-3 Requirements for Expanded Definition of Byproduct 11/30/2010 Final No Comments Material ML090550203 03/23/2009 Parts 20, 30, 31, 32, 33, 35, 61 and 150 ML090760101 72 FR 55864 2007-4 Order Imposing Fingerprinting Requirements and 06/05/2008 License No Comments Criminal History Records Check Requirements for Condition 03/12/2008 Unescorted Access to Certain Radioactive Material ML080530108 ML080720050 NRC Order EA-07-305 72 FR 70901 2008-1 Occupational Dose Records, Labeling Containers, 02/15/2011 Final No Comments and Total Effective Dose Equivalent ML090550203 03/23/2009 Parts 19 and 20 ML090760101 72 FR 68043 2009-1 Medical Use of Byproduct Material - Authorized 09/28/2012 Final No Comments User Clarification ML113202693 12/21/2011 Part 35 ML113400191 74 FR 33901 2011-1 Decommissioning Planning 12/17/2015 Proposed No Comments Parts 20, 30, 40 and 70 ML14234A134 10/21/2014 76 FR 35512 ML14232A319 Final No Comments ML15237A085 10/15/2015 ML15236A292 8

2011-2 Licenses, Certifications, and Approvals for Materials 11/14/2014 Proposed No Comments Licensees ML14234A134 10/21/2014 Parts 30, 36, 39, 40, 70 and 150 ML14232A319 76 FR 56951 Final No Comments ML15237A085 10/15/2015 ML15236A292 2012-1 Change of Compatibility of 01/25/2015 Proposed No Comments Parts 31.5 and 31.6 ML14234A134 10/21/2014 (See RATS ID: 2001-1 for Rule text) ML14232A319 77 FR 3640 Final No Comments ML15237A085 10/15/2015 ML15236A292 2012-2 Advance Notification to Native American Tribes of 08/10/2015 Proposed No Comments Transportation of Certain Types of Nuclear Waste ML14234A134 10/21/2014 Part 71 ML14232A319 77 FR 34194 Final No Comments ML15237A085 10/15/2015 ML15236A292

2012-4 Requirements for Distribution of Byproduct Material 10/23/2015 Proposed No Comments Parts 30, 31, 32, 40 and 70 ML14234A134 10/21/2014 77 FR 43666 ML14232A319 Final No Comments ML15237A085 10/15/2015 ML15236A292

  • 2015-2 Safeguards Information - Modified Handling 01/28/2018 Proposed No Comments Categorization, Change for Materials Facilities ML18032A474 03/16/2018 Parts 30, 37, 73 and 150 ML18032A473 79 FR 58664, 80 FR 3865 10
  • 2015-3 Revisions to Transportation Safety Requirements 07/13/2018 Proposed Comments and Harmonization with International Atomic *extended to ML18032A474 03/16/2018 Energy Agency Transportation Requirements 08/15/2020 ML18032A473 Part 71 See STC 17-060 80 FR 33987
  • N/A Provisions corresponding to N/A Proposed Comment Comment re: 71.97(a)

Parts 30, 35, 70, 71 150 not associated with specific ML18032A474 03/16/2018 RATS IDs ML18032A473 11

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